Sterile irrigating fluids, commonly consisting of distilled water, normal saline, or physiological solutions of sorbitol or glycine, are widely used for post-operative irrigation, for flushing wounds and body passages, cavities, and other areas undergoing surgical examination or operation. For example, continuous or intermittent irrigation is commonly required during transurethral prostatic resections and for cystoscopic examinations. Surgical apparatus particularly suitable for irrigation in transurethral resections is disclosed in co-owned U.S. Pat. No. 3,677,248.
The manner of administration of such irrigating fluids depends on the type of examination or treatment involved and particularly on the quantities of fluid required. Relatively large quantities are frequently needed for flushing purposes and, in those cases, the surgeon or assistant may simply remove the closure and pour the fluid directly from the bottle. In other instances, as where a stream of irrigating liquid is to be directed through a cystoscope or resectoscope, the instrument is attached to the flexible tubing of an administration set with the connector of that set being secured to the bottle in place of its original closure.
Administration sets for irrigation fluids are available with different forms of bottle connectors but each form has some shortcomings in terms of cost, inconvenience of use, and/or possible risks of fluid contamination. For example, one connector takes the form of a threaded cap to which the flexible tubing of the administration set is permanently secured. Substitution of that cap for the original threaded bottle cap obviously requires considerable manipulation and time. In another arrangement, the connector comprises a plug which need only be inserted into the mouth of the bottle; however, such a procedure still requires prior removal of the bottle's original cap.
One aspect of this invention therefore lies in providing a dual-purpose closure for an irrigation bottle and, specifically, a closure which constitutes the original closure of the bottle, which is to be left in place when the irrigating fluid is to be administered through an administration set, and which is to be removed only if circumstances require that fluid be poured from the bottle. While it is recognized that closures with piercable membranes are widely used for intravenous administration of blood and parenteral fluids, such closures are ordinarily secured against removal (see, for example, U.S. Pat. No 2,730,097) and would be clearly unsuitable for use in the administration of irrigation solutions for that reason alone and also because of their relatively expensive, ordinarily multiple-piece, construction.
This invention is concerned with a relatively simple, inexpensive one-piece molded plastic closure which functions as the original closure for the bottle of surgical irrigation fluid and which is readily unthreaded from the bottle when fluid is to be poured from that bottle. When instead the fluid is to be drained through an administration set, the imperforate closure is left in place and the connector of the administration set is frictionally coupled to the closure with a hollow spike portion of the connector piercing a wall portion of the closure. Thus, either closure removal or administration set attachment may be easily and quickly accomplished-- advantages which are particularly important in the surgical field where any delays may have serious consequences.
The one-piece closure is formed of semi-rigid plastic and has a generally cylindrical side wall, an annular top wall, a tubular sleeve communicating with the central opening of the top wall, and a bottom wall closing the lower end of the sleeve. Within the sleeve, at a level just below the top wall, is an annular rib which projects into the cavity of the sleeve and which provides a primary sealing zone for slidably and sealingly engaging the outer surface of a connector spike insertable into the sleeve to pierce the bottom wall of that sleeve and to place the interior of the irrigation bottle in flow communication with an administration set. In the disclosed embodiment, the sleeve is downwardly tapered and has along its inside surface a secondary sealing zone spaced between the primary zone and the bottom wall of the sleeve. The bottom wall has a dome-shaped upper surface which facilitates proper positioning and cutting action of the piercing spike. The spike is provided with an angularly-beveled cutting edge terminating at its lower end in a peripherally-disposed tip, has a lower portion of smaller external diameter than the upper portion thereof, and includes a separate airway for the introduction of filtered air into the bottle as its contents are drained. Because of an enlarged recess formed in the heel portion of the spike, insertion of the spike through the bottom wall of the closure results in the formation of a flap which is pushed aside (so that it does not obstruct liquid flow) but is not detached from the closure.
Other features, advantages, and objects of the invention will become apparent from the specification and drawings.